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Gynatrof is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.

Gynatrof® is a personal lubricant intended to moisturize, lubricate, and enhance the ease and comfort of intimate sexual activity as well as supplement the body's natural lubrication. The product is supplied with a reusable, non-sterile, single-patient use applicator. Gynatrot® is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The product is intended for over-the-counter use.

The device formulation consists of Aqua/Water, Hydroxyethylcellulose, Lactic Acid, Polysorbate 20, Potassium Sorbate, Sodium Hyaluronate, Sodium Levulinate, Tocopherol. Gynatrof® is supplied in a 50 mL white tube; each tube contains sufficient product for 20 applications using the reusable applicator.

The provided text describes the 510(k) premarket notification for the medical device Gynatrof®. It focuses on demonstrating substantial equivalence to a predicate device, not on evaluating the device's performance against specific acceptance criteria in a clinical study involving human patients or complex AI algorithms.

Therefore, many of the requested elements are not applicable to this submission. The information provided is primarily related to the device specifications and non-clinical performance data which are used to show that the device is as safe and effective as a legally marketed predicate device.

Here's a breakdown of the applicable and non-applicable requested information:

1. A table of acceptance criteria and the reported device performance

The document provides "Device Specifications" which can be considered acceptance criteria for the physical and chemical properties of the lubricant. It then states that a shelf-life study evaluated these specifications, and the results demonstrated the device's stability over 12 months.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly detailed in the provided text. The studies mentioned are non-clinical (biocompatibility, condom compatibility, shelf-life). These types of studies typically involve laboratory samples of the product itself and possibly in vitro or animal models for biocompatibility, rather than human test sets or patient data.

• Sample Size: Not specified for each test, but standard for laboratory testing of a manufactured product. For example, condom compatibility testing would likely involve a specific number of condoms and lubricant samples as per the ASTM standard.
• Data Provenance: Not specified, but generally from the manufacturer's testing facilities or contract research organizations (CROs) that perform these standardized tests. These are prospective tests conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for the device specifications comes from standardized test methods (e.g., USP <791> for pH) and the results derived from those methods. Biocompatibility and condom compatibility also rely on standardized methodologies and measurable outcomes, not expert consensus interpretation in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not a clinical study involving human interpretation of medical data, there is no need for adjudication methods typical of multi-reader studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by reference to:

• Standardized Test Methods: e.g., USP <791> for pH, USP <912> for viscosity, USP <51> for Antimicrobial Effectiveness, USP <61> for Total Microbial Count, USP <62> for Absence of Pathogenic Organisms.
• International Standards for Biocompatibility: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Vaginal Irritation), ISO 10993-11 (Acute Systemic Toxicity).
• ASTM Standard for Condom Compatibility: ASTM D7661-18.
  The "ground truth" for these tests is therefore the objective, measurable outcome of these standardized scientific and engineering tests, not subjective expert consensus or clinical outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The product formulation is developed through research and development, and then tested for specifications.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" in the context of an AI algorithm. The product formulation and manufacturing process are developed to meet the desired specifications and performance characteristics, which are then verified through the non-clinical testing described.

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